Usability Engineering for Medical Devices

Clinical Performance Studies under the IVDR – What’s required, what has changed?

General Background

Usability is an important requirement for medical devices under the European Union’s Medical Devices Regulation (EU MDR). The EU MDR requires medical devices to be designed and manufactured in such a way that they are safe and easy to use for their intended purpose, including by their intended user groups.

When it comes to medical devices, usability is not only considering ease of use. It’s more about enabling and ensuring the safe use of the device. In fact, the industry standard for usability engineering of medical devices is IEC 62366-1, which defines usability as a characteristic of the user interface that facilitates use, increases effectiveness and efficiency, and leads to user satisfaction in the intended use environment.

But what exactly is the usability engineering? It is a process that allows manufacturers to assess and mitigate risks associated with correct use during normal use. It is an essential part of the design control and risk management processes that ensure the safety and effectiveness of medical devices.

Support & Training

Contact AKRA TEAM for support, hands on implementation services and personalized training by experts with key competencies in the areas listed below.

Key steps for usability under the EU MDR include:

Our Services


AKRA TEAM offers training on drafting usability documentation to meet the expectations of the legislation and applicable standard. This would avoid delays during technical documentation assessments by notified bodies.

Process and Templates Development

AKRA TEAM has proven procedure and document templates available for all aspects of the usability documentation including:

  • Usability procedure/process
  • Device usability plans
  • Formative usability testing protocols and reports
  • Summative usability testing protocols and reports
  • Device usability summary reports

Gap Assessment

AKRA TEAM offers comprehensive gap assessments of usability documentation to highlight areas of risk or improvement prior to submission. AKRA TEAM will rank risks from high to low while offering mitigations to close any identified gaps.


AKRA TEAM has an experienced team of medical writers, clinicians, regulatory and quality experts available to write all aspects of usability documentation and support change assessment for all device categories and risk-classes. We offer custom tailored solutions or comprehensive solutions to addresses the needs of any manufacturer.

Continuous update of documentation

AKRA TEAM additionally offers solutions for continuous documentation updates and review of usability documentation. AKRA TEAM will schedule and revise documentation at defined intervals to ensure regulatory compliance is maintained according to the expectations of the applicable legislation.

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